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Managing Dysexecutive Syndrome (DS): CIHR 2011-2014

Primary Purpose

Traumatic Brain Injury, Cerebrovascular Accident (CVA), Acquired Brain Injury

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Conventional rehabilitation.

Novel rehabilitation approach

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring participation, activities of daily living, brain injuries, executive function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

fluent in written and spoken English,
have sustained (1) a moderate to severe TBI as defined by a 6-hour GCS of 12 or less OR (2) complicated mild TBI with GCS 13-15 and associated abnormal findings on CT or MRI scan OR (3) other form of acquired brain injury (ABI) that is not related to a congenital, developmental or degenerative disorder but which occurred through a medical problem or disease process including stroke,

Exclusion Criteria: other significant neurological or psychiatric history such as multiple sclerosis or psychiatric illness requiring hospitalization, concurrent moderate to severe depression.

Sites / Locations

Baycrest Centre for Geriatric Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional rehabilitation

Novel rehabilitation approach

Arm Description

In-home work on problems in daily living.

Outcomes

Primary Outcome Measures

Change in performance on COPM

Canadian Occupational Performance Measure: standardized interview

Secondary Outcome Measures

DEX, IADL profile

Perceived and observed impact of dysexecutive syndrome in everyday life

Full Information

NCT ID

NCT01414348

First Posted

August 10, 2011

Last Updated

January 26, 2015

Sponsor

Baycrest

1. Study Identification

Unique Protocol Identification Number

NCT01414348

Brief Title

Managing Dysexecutive Syndrome (DS): CIHR 2011-2014

Official Title

Managing the Dysexecutive Syndrome Following Traumatic Brain Injury: An Ecologically Valid Rehabilitation Approach

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baycrest

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Successful community participation following acquired brain injury (ABI) continues to be an elusive goal for patients, clinicians and researchers. Our pilot work shows that community dwelling survivors of ABI can significantly improve performance on self-identified real- world performance problems and that they can transfer this learning to improve goals not trained in the treatment sessions. We will compare two types of rehabilitation intervention using a randomized controlled trial. We will also interview survivors, their significant others and clinicians regarding their experiences with each intervention to help us discover what works best.

Detailed Description

Executive dysfunction is endemic after severe acquired brain injuries (ABIs) and is highly associated with long-lasting psychosocial distress, problems in a multiplicity of everyday activities and overall reduced quality of life. There is increasing evidence to suggest that a novel behavioral intervention is a treatment of choice for executive dysfunction. However few studies have addressed ecological relevance: failing to take into account the significant impact of the complex settings of real life on executive function. More data are desperately needed in this area given the devastating consequences of ABI. We propose to investigate the benefits of two community- based interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury, Cerebrovascular Accident (CVA), Acquired Brain Injury

Keywords

participation, activities of daily living, brain injuries, executive function

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional rehabilitation

Arm Type

Active Comparator

Arm Description

In-home work on problems in daily living.

Arm Title

Novel rehabilitation approach

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Conventional rehabilitation.

Intervention Description

1 hour / 2x / week for up to 15 sessions

Intervention Type

Behavioral

Intervention Name(s)

Novel rehabilitation approach

Intervention Description

1 hr, 2x/week for up to 15 sessions

Primary Outcome Measure Information:

Title

Change in performance on COPM

Description

Canadian Occupational Performance Measure: standardized interview

Time Frame

pre, post, 3 month follow-up

Secondary Outcome Measure Information:

Title

DEX, IADL profile

Description

Perceived and observed impact of dysexecutive syndrome in everyday life

Time Frame

pre, post, 3 month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: fluent in written and spoken English, have sustained (1) a moderate to severe TBI as defined by a 6-hour GCS of 12 or less OR (2) complicated mild TBI with GCS 13-15 and associated abnormal findings on CT or MRI scan OR (3) other form of acquired brain injury (ABI) that is not related to a congenital, developmental or degenerative disorder but which occurred through a medical problem or disease process including stroke, Exclusion Criteria: other significant neurological or psychiatric history such as multiple sclerosis or psychiatric illness requiring hospitalization, concurrent moderate to severe depression.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deirdre D Dawson, PhD

Organizational Affiliation

Baycrest centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baycrest Centre for Geriatric Care

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6A2E1

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

24053695

Citation

Dawson DR, Anderson ND, Binns MA, Bottari C, Damianakis T, Hunt A, Polatajko HJ, Zwarenstein M. Managing executive dysfunction following acquired brain injury and stroke using an ecologically valid rehabilitation approach: a study protocol for a randomized, controlled trial. Trials. 2013 Sep 22;14:306. doi: 10.1186/1745-6215-14-306.

Results Reference

derived

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Managing Dysexecutive Syndrome (DS): CIHR 2011-2014

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